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Exploration of Subtypes of Gastroparesis and Gastroparesis-like Symptoms based on Physiological Testing

Award Number: U01DK073974
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/15/2006
PERIOD OF PERFORMANCE END DATE: 07/31/2027

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Exploration of Subtypes of Gastroparesis and Gastroparesis-like Symptoms based on Physiological Testing - Project Summary This project includes the continuation of studies currently conducted by NIDDK Gastroparesis Clinical Research Consortium (GpCRC) and one new protocol proposed by this site that is to be carried out by the Consortium. The mission of the GpCRC is to improve understanding of the pathogenesis, etiology, and treatment of symptoms associated with GP. Improved precision in diagnostic and therapeutic approaches are needed for patients with GP and for patients with GP- like symptoms with normal gastric emptying, a disorder termed functional dyspepsia or FD in this project. Thus, our aims are: 1) to continue the important studies that were begun in the third funding period (Gastroparesis Registry 3 or GpR3); 2) to further define major subtypes of GP by measuring gastric myoelectrical activity (GMA), gastric accommodation and sensitivity, antral – pyloro contractility, and pyloric distensibility; and 3) to explore the efficacy of balloon dilation of the pylorus in reducing symptoms in patients with GP and FD in a new protocol to be carried out by the Consortium. Studies from GpR3 to be continued and completed in GpR4 include: The GP Registry, Buspirone for Early Satiety and Symptoms of Gastroparesis: A Multicenter, Randomized, Placebo- Controlled, Double-Masked Trial (BESST), Understanding the Pathological Basis of Gastroparesis and Identification of the Molecular Factors Involved in its Pathogenesis (PBG) Study, and Pyloric Sphincter Abnormalities in Patients with Gastroparesis Symptoms (PSAGS). Two subtypes of GP and FD based on GMA in response to the water load satiety test have been identified: one with normal 3 cpm (GMA) and the other with gastric dysrhythmias. Normal 3 cpm GMA controls normal gastric peristaltic contractions and requires normal numbers of interstitial cells of Cajal (ICCs). ICCs are severely depleted in GP and modestly depleted in FD. Loss of ICCs results in loss of 3 cpm GMA and increased gastric dysrhythmias which are associated with delays in gastric emptying and symptoms like nausea. Endoscopic pyloric therapies reduce symptoms in patients with GP and 3 cpm GMA, indicating antro-pyloro outflow dysfunction has a role in the genesis of symptoms. Our hypothesis is that patients with GP and FD who have normal 3 cpm and poor pyloric distensibility will have greater reduction in symptoms after balloon dilation of the pylorus compared with patients with gastric dysrhythmias. Patients with GP (or FD) with 3 cpm GMA or gastric dysrhythmias and poor pyloric distensibility will undergo balloon dilation of the pylorus in a single blind study. Identifying subtypes of GP and FD based on GMA will help to provide a more rational approach for selecting patients for pyloric therapy and improving treatment outcomes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $271,578 )
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	19	7/31/2025	NON-COMPETING CONTINUATION	$271,578
														Subtotal = $271,578

Issue Date FY: 2024 ( Subtotal = $372,000 )
2024	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	18	7/31/2024	NON-COMPETING CONTINUATION	$372,000
														Subtotal = $372,000

Issue Date FY: 2023 ( Subtotal = $387,500 )
2023	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	17	8/8/2023	NON-COMPETING CONTINUATION	$387,500
2023	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	16	6/27/2023	COMPETING CONTINUATION	$281,021
2023	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	6/27/2023	NON-COMPETING CONTINUATION	-$281,021
														Subtotal = $387,500

Issue Date FY: 2022 ( Subtotal = $387,500 )
2022	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	16	8/29/2022	COMPETING CONTINUATION	$387,500
2022	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	16	9/19/2022	COMPETING CONTINUATION	$0
														Subtotal = $387,500

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	8/12/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $495,759 )
2020	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	15	9/2/2020	SUPPLEMENT FOR EXPANSION	$108,259
2020	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	15	8/11/2020	NON-COMPETING CONTINUATION	$387,500
														Subtotal = $495,759

Issue Date FY: 2019 ( Subtotal = $387,500 )
2019	2019	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	14	8/22/2019	NON-COMPETING CONTINUATION	$387,500
														Subtotal = $387,500

Issue Date FY: 2018 ( Subtotal = $387,500 )
2018	2018	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	13	9/12/2018	NON-COMPETING CONTINUATION	$387,500
														Subtotal = $387,500

Issue Date FY: 2017 ( Subtotal = $387,500 )
2017	2017	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	12	9/1/2017	NON-COMPETING CONTINUATION	$387,500
2017	2016	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	11	2/9/2017	COMPETING CONTINUATION	$105,038
2017	2015	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	2/9/2017	NON-COMPETING CONTINUATION	-$105,038
														Subtotal = $387,500

Issue Date FY: 2016 ( Subtotal = $387,500 )
2016	2016	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	11	9/23/2016	COMPETING CONTINUATION	$387,500
2016	2015	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	9/20/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $387,500

Issue Date FY: 2015 ( Subtotal = $303,091 )
2015	2015	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	9/9/2015	NON-COMPETING CONTINUATION	$303,091
														Subtotal = $303,091

Issue Date FY: 2014 ( Subtotal = $303,091 )
2014	2014	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	9/16/2014	NON-COMPETING CONTINUATION	$303,091
														Subtotal = $303,091

Issue Date FY: 2013 ( Subtotal = $302,382 )
2013	2013	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	9/4/2013	NON-COMPETING CONTINUATION	$302,382
														Subtotal = $302,382

Issue Date FY: 2012 ( Subtotal = $303,091 )
2012	2012	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	9/14/2012	NON-COMPETING CONTINUATION	$303,091
														Subtotal = $303,091

Issue Date FY: 2011 ( Subtotal = $361,912 )
2011	2011	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	6	9/1/2011	COMPETING CONTINUATION	$361,912
2011	2010	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	8/30/2011	NON-COMPETING CONTINUATION	$0
2011	2009	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	12/3/2010	SUPPLEMENT FOR EXPANSION	$0
2011	2009	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	4	9/15/2011	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $361,912

Issue Date FY: 2010 ( Subtotal = $285,970 )
2010	2010	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	6/24/2010	NON-COMPETING CONTINUATION	$285,970
2010	2009	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Trans-NIH Recovery Act Research Support	001	4	7/22/2010	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $285,970

Issue Date FY: 2009 ( Subtotal = $764,019 )
2009	2009	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	4	9/30/2009	SUPPLEMENT FOR EXPANSION	$270,188
2009	2009	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Trans-NIH Recovery Act Research Support	001	4	9/1/2009	SUPPLEMENT FOR EXPANSION	$150,000
2009	2009	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	6/15/2009	NON-COMPETING CONTINUATION	$343,831
														Subtotal = $764,019

Issue Date FY: 2008 ( Subtotal = $332,103 )
2008	2008	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Digestive Diseases and Nutrition Research	000	3	4/16/2008	NON-COMPETING CONTINUATION	$332,103
														Subtotal = $332,103

Issue Date FY: 2007 ( Subtotal = $344,482 ) (Continued on the next page)
Grand Total All Awards = $7,112,757

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Exploration of Subtypes of Gastroparesis and Gastroparesis-like Symptoms based on Physiological Testing

Award Number: U01DK073974

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/15/2006

PERIOD OF PERFORMANCE END DATE: 07/31/2027

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